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NCT01288495 · ClinicalTrials.gov registry record · NA
Randomized Control Trial of L-Alanine and Placebo in Fructose Intolerance
A NA study, sponsored by Augusta University.
- Terminated
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT01288495: Clinical Trial NA study, sponsored by Augusta University.
NCT01288495 is a NA study that was terminated before completion, run by Augusta University. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01288495, a NA study, was terminated before completion, sponsored by Augusta University.
- TERMINATED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
Data suggest that alanine may facilitate the intestinal absorption of fructose in patients with DFI and thereby may decrease GI symptoms. We hypothesize that the ingestion of supplemental L-alanine along with mixed meals or snacks that contain foods with free fructose or high fructose content will decrease GI symptoms in subjects with dietary fructose intolerance by facilitating intestinal absorption of fructose. Aim: To investigate the effects of co- administration of equi-molar doses of L-alanine or placebo on the occurrence of GI symptoms in subjects with dietary fructose intolerance, in a randomized, double blind, cross over study. Methods: We propose to investigate the effects of co-administration of equi-molar doses of L-alanine or placebo on the occurrence of GI symptoms in 70 subjects with dietary fructose intolerance, in a randomized, double blind, cross over study. Data Analysis: The primary outcome measure will be a comparison of baseline breath sample values and study visit breath sample values. Additionally, we will assess subject-reported occurence and severity of nine gastrointestinal symptoms during the test on a visual analog scale (VAS). Expected Results: We anticipate that dietary fructose intolerance (DFI) symptoms will improve with ingestion of supplemental L-alanine (along with foods containing free fructose or high fructose content). We additionally expect treatment of DFI with administration of L-alanine powder to be more practical than co-ingestion of alanine-rich foods, and more convenient for patients.
Primary Outcome
Change in GI symptom score with alanine \& placebo, when compared to the baseline
Interventions
- DIETARY_SUPPLEMENT Metamucil
- DIETARY_SUPPLEMENT supplemental L-alanine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-12 |
| Phase | NA |
Why NCT01288495 stopped before completion
NCT01288495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Metamucil is the first listed.
NCT01288495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01288495 about?
NCT01288495 is a clinical study titled "Randomized Control Trial of L-Alanine and Placebo in Fructose Intolerance". Data suggest that alanine may facilitate the intestinal absorption of fructose in patients with DFI and thereby may decrease GI symptoms. We hypothesize that the ingestion of supplemental L-alanine along with mixed meals or snacks that contain foods with free fructose or high fructose content will ...
What is the current status of trial NCT01288495?
This trial is currently terminated. It is a NA study. The enrollment target is 15 participants. The study started on 2009-02. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01288495?
The interventions under investigation include: Metamucil (DIETARY_SUPPLEMENT), supplemental L-alanine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01288495?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01288495's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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